MIRCERA is administered less frequently than other erythropoiesis stimulating agents (ESAs) due to the longer elimination half-life.
Treatment with MIRCERA has to be initiated under the supervision of a healthcare professional.
Treatment of anaemic patients with chronic kidney disease:
The solution can be administered subcutaneously (SC) or intravenously (IV), according to clinical preference.
MIRCERA can be injected subcutaneously in the abdomen, arm or thigh. All three injection sites are equally suitable for subcutaneous injection with MIRCERA.
It is recommended that haemoglobin is monitored every two weeks until stabilised, and periodically thereafter.
As recommended in current guidelines, the rate of increase in Hb and the target Hb should be determined for each patient individually. In CKD patients, the aim of treatment is to reach a target Hb level of 10-12 g/dL. Patients should be monitored closely to ensure that the lowest effective dose of MIRCERA is used to provide adequate control of the symptoms of anemia.
Patients currently not treated with an Erythropoiesis Stimulating Agent: Patients not on dialysis:
The recommended starting dose is 1.2 microgram/kg body weight administered once every month as a single subcutaneous injection. Alternatively, a starting dose of 0.6 microgram/kg body weight may be administered once every two weeks as a single IV or SC injection.
Patients on dialysis:
The recommended starting dose of 0.6 microgram/kg body weight may be administered once every two weeks as a single IV or SC injection.
The dose of MIRCERA may be increased by approximately 25 to 50% of the previous dose if the rate of rise in haemoglobin is less than 1.0 g/dL (0.621 mmol/L) over a month. Further increases of approximately 25 to 50% may be made at monthly intervals until the individual target haemoglobin level is obtained.
If the rate of rise in haemoglobin is greater than 2 g/dL (1.24 mmol/L) in one month or the haemoglobin levels exceed 12g/dL, the dose is to be reduced by approximately 25 to 50%.
If the haemoglobin level exceeds 13 g/dL (8.07 mmol/L), therapy is to be interrupted until the haemoglobin level falls below 13 g/dL and then restarted with approximately 50% of the previously administered dose. After dose interruption a haemoglobin decrease of approximately 0.35 g/dL per week is expected.
Patients treated once every two weeks whose haemoglobin concentration is in the target range may receive MIRCERA administered once monthly using the dose equal to twice the previous once every two weeks dose. Dose adjustments should not be made more often than once a month.
Patients currently treated with an Erythropoiesis Stimulating Agent:
Patients currently treated with an ESA can be converted to MIRCERA administered once a month or, if desired, once every two weeks as a single IV or SC injection. The starting dose of MIRCERA is based on the calculated previously given weekly dose of darbepoetin alfa or epoetin at the time of substitution as described in Table 1, as follows. The first injection of MIRCERA should be administered at the next scheduled dose of the previously administered darbepoetin alfa or epoetin. (See Table 1.)
Click on icon to see table/diagram/image
If a dose adjustment is required to maintain the target haemoglobin concentration above 10 g/dL, the monthly dose may be adjusted by approximately 25%.
If the rate of rise in haemoglobin is greater than 2 g/dL (1.24 mmol/L) over a month or the haemoglobin levels exceed 12 g/dL, the dose is to be reduced by approximately 25 to 50%. If the haemoglobin level exceeds 13 g/dL (8.07 mmol/L), therapy is to be interrupted until the haemoglobin level falls below 13 g/dL and then restarted with approximately 50% of the previously administered dose. After dose interruption a haemoglobin decrease of approximately 0.35 g/dL per week is expected.
Dose adjustments should not be made more often than once a month.
Treatment interruption: Treatment with MIRCERA is normally long-term. However, it can be interrupted at any time, if necessary.
Missed dose: If one dose of MIRCERA is missed, the missed dose should be administered as soon as possible and administration of MIRCERA is to be restarted at the prescribed dosing frequency.
Special Dosage Instructions: Paediatric use:
No dose recommendations can be made for use in patients aged less than 18 years due to the limited data on safety and efficacy (see Pharmacology: Pharmacodynamics: Clinical/Efficacy Studies under Actions).
No adjustment of the starting dose is required in patients aged 65 years or older (see Use in the Elderly under Precautions).
No adjustments of the starting dose nor dose modification rules are required in patients with any degree of hepatic impairment (see Pharmacology: Pharmacokinetics: Pharmacokinetics in Special Populations under Actions).
Route of Administration:
Subcutaneous or intravenous.